Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
upon ECHA´s approval
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out:
N-(2-Ethylhexyl)isononan-1-amide
- Name of the substance for which the testing proposal will be used
N-(2-Ethylhexyl)isononan-1-amide

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies
No available GLP studies on the substances for the endpoint ‘developmental toxicity’.
- Available non-GLP studies
No available non-GLP studies on the substances for the endpoint ‘developmental toxicity’.
- Historical human data
No human data suggesting developmental toxicity are available for this substance.
- (Q)SAR
No validated (Q)SAR’s exist for this endpoint for this substance. From the available data, no indication of a specific mode of action regarding reproductive toxicity exist for this substance.
- In vitro methods
In accordance with ECHA’s guidance on the information requirements and chemical safety assessment (R7a), no regulatory accepted alternative in vitro tests exist to replace the OECD TG 414 ‘Prenatal Developmental Toxicity Study’ in animals because alternative approaches do not provide equivalent information with regard to classification and labelling.
- Weight of evidence
Insufficient reliable data are available to complete the IUCLID requirements as a weight of evidence approach.
- Grouping and read-across
No or limited information exists for analogous substances regarding this endpoint.
- Substance-tailored exposure driven testing [if applicable]
Not applicable
- Approaches in addition to above [if applicable]
Not applicable
- Other reasons [if applicable]
Not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- The study is proposed and upon ECHA's approval. The study will be conducted under GLP and according to internationally accepted testing guidelines.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
It is proposed to use the oral route and rats as appropriate test species

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Test item Antimussol ZJ
Batch number ESD0017844
CAS RN (a.s.) 93820-33-8
EG No. 298-613-3
Active substance/Content (certified) N-(2-Ethylhexyl)-isononan-1-amide / 98.5 %
Sum Formula C17H35NO
Density 0.87 g/cm3 (20°C)
Appearance Clear, yellowish, viscous, liquid
Melting Point ≤ -30°C
Boiling Point 328 ± 5°C
Viscosity 85 mPa.s (20°C)
pH 6 – 7 (20°C, 10 g/L in ethanol/water 1:1)
Water solubility ca. 0.5 mg/L (20°C)
Stability under test conditions Not applicable
Expiry date 2017-07-01
Recommended storage Cool and dry (2 – 8°C)

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion